Comparing radial and femoral access methods for cardiac catheterization

Radial Vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)

This study is testing whether using the wrist or the groin for heart catheterization is better for patients in terms of satisfaction and complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3266 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Minneapolis Heart Institute Foundation (Academic / other)
• Locations: 6 sites (San Francisco, California and 5 other locations)
• Trial ID: NCT04077762 on ClinicalTrials.gov

What this trial studies

This interventional study aims to compare the effectiveness of radial access versus state-of-the-art femoral access in patients undergoing cardiac catheterization without ST-segment elevation acute myocardial infarction. Participants will be randomly assigned to one of the two access methods, with a secondary randomization within the femoral group to evaluate the use of different gauge needles. The study will assess patient satisfaction and the incidence of vascular access complications associated with each method.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing diagnostic angiography or planned PCI and are eligible for either radial or femoral access.

Not a fit: Patients requiring primary PCI for STEMI or those with specific vascular access issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved patient outcomes and satisfaction by identifying the safer access method for cardiac catheterization.

How similar studies have performed: Previous studies have shown promising results in favor of radial access, suggesting that this approach may reduce complications compared to femoral access.

Eligibility criteria

Inclusion Criteria:

* Age 18 years and older
* Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
* Has provided informed consent and agrees to participate
* Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access

Exclusion Criteria:

* Primary PCI for STEMI
* Planned right heart catheterization
* Valvular heart disease requiring valve surgery within 30 days after the index procedure
* Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
* Peripheral arterial disease prohibiting vascular access
* Presence of bilateral internal mammary artery coronary bypass grafts
* International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure
* Planned staged PCI within 30 days after index procedure.
* Any planned surgeries within 30 days after index procedure
* Planned dual arterial access (for example for chronic total occlusion PCI)
* Coexisting conditions that limit life expectancy to less than 30 days
* Positive pregnancy test

Where this trial is running

San Francisco, California and 5 other locations

• San Francisco VA Medical Center — San Francisco, California, United States (Recruiting)
• Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
• Joseph Maxwell Cleland Atlanta VA Medical Center — Decatur, Georgia, United States (Recruiting)
• Henry Ford Hospital — Detroit, Michigan, United States (Not_yet_recruiting)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (Recruiting)

Study contacts

• Principal investigator: Emmanouil Brilakis, MD, PhD — Minneapolis Heart Institute Foundation
• Study coordinator: Bavana Rangan, BDS, MPH, CCRP

Conditions Patient Satisfaction; Vascular Access Complication